Currently, rules established by the U.S. Food and Drug Administration (FDA) require that product use labeling information presented in document form on printed paper be dispensed on or within the package from which the drug is to be dispensed. See 21 C.F.R. §201.110(c)(1). One goal of this regulation is to ensure that the pharmacist dispensing the drug or medicine has access to the full prescribing information. Because the paper document containing the labeling information is physically attached (or inserted into) the drug packaging, the prescribing information has become referred to as a “package insert.”
A number of steps are required to produce and place the prescribing information with each drug container or bottle. While the process varies to a certain extent with different drug manufacturers, the following steps are generally required to produce these package inserts. First, text (as well as any illustrations or graphical features) for the prescribing information is finalized within the drug manufacturing company. This first step often requires consultation with and ultimate approval by the FDA. The text and any other information is then finalized using desktop publishing software. The type is set using the desktop publishing software and proofs are printed for review. Once the proofs are read and approved, they are sent to a printer for printing. The printed labeling is then folded and warehoused until needed on the manufacturing line. Finally, the labeling (i.e., package insert) is attached or inserted into product containers and bottles.
Unfortunately, there are a number of disadvantages with the current paper-based package inserts. First, a significant amount of expense both in material costs as well as labor is expended in printing up and placing the package inserts into each drug package. These costs include the personnel specific to labeling production and printing, costs of paper and printing, packaging machines which fold and attach or insert the labeling, costs associated with warehousing the package inserts, quality assurance costs, as well as waste labeling due to changes and/or revisions in package inserts.
The above-described current practice of using individual package inserts also suffers from the limitation that it may take a significant amount of time for a new label to be associated with a current prescribed drug or medicine. For example, the above-described process may take several weeks for a new product. Even to replace or modify a package insert for a currently marketed product may take a few weeks due to the need to coordinate all these steps. Drug company policies such as “use up and replace” when labeling changes are minor further delay access to the new labeling information.
In addition, in the current package insert-based system, pharmacists or other health care professionals may not have access to the most current information for a particular drug. Typically, the time from manufacturing to dispensing at a pharmacy varies greatly depending on the particular drug. For frequently prescribed and dispensed products which are manufactured and dispensed immediately, this time period may be as little as two weeks. However, for infrequently prescribed and dispensed products that may be manufactured only once a year, the labeling may well be over a year old before the product even reaches the pharmacy. Similarly, the time from when a labeling change is made to the time when a physician receives the updated information may vary greatly. For physicians that prescribe high volumes of a drug, a sales representative may visit physicians on a monthly basis. Still other physicians may not be visited at all by a sales representative. Some physicians may prefer, for example, to review periodic published third-party compilations for current prescribing information. Other physicians may be notified by advertisements or promotional materials generated by the drug manufacturing company.
There are problems, however, with the timeliness of these notifications. Third-party publications and/or periodicals may be as much as one year out of date. Company-produced materials are more current, but these may contain prescribing information that has been changed since the time of printing.
The paper-based package inserts often have poor readability. Due to the expanding amount of information required in the product labeling, the size of the package insert is increasing while the size of the font used has been progressively decreasing. Many package inserts are oversized or long “scrolls” which are hard to handle and read.
There thus is a need for an alternative system and method of providing pharmacists or other health professionals with up-to-date and readable prescription information for drugs and medicines.